Events

ADVIA Centaur and Centaur XP Instrument Systems (immuno-assay analysers). An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Ltd Diagnostics Division 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2012-RN-01139-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-11-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01139-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Siemens healthcare diagnostics has confirmed occurrences of the system either:- failing to detect that the wash 1 bottle and reservoir is empty, or- incorrectly indicating that the wash 1 bottle and reservoir is empty when it is actually full.If the system fails to detect an empty wash 1 bottle and reservoir, it can continue to process samples and product erroneous but believable results which are falsely high or low (depending if the assay architecture is direct or indirect). this issue potentially affects only those assays that use wash 1.
  • 조치
    Siemens is providing work around instructions for users to follow.

Device

ADVIA Centaur and Centaur XP Instrument Systems (immuno-assay analysers). An in vitro diagnostic ...
  • 모델명 / 제조번호(시리얼번호)
    ADVIA Centaur and Centaur XP Instrument Systems (immuno-assay analysers). An in vitro diagnostic medical device (IVD)Catalogue numbers: 078-A001-xx and 078-A011-03 (respectively)
  • Manufacturer
    Siemens Ltd Diagnostics Division

Manufacturer

Siemens Ltd Diagnostics Division